The US Food and Drug Administration (FDA) has granted Fast Track designation to Corbus Pharmaceuticals' investigational drug Resunab for the treatment of systemic sclerosis (scleroderma).
Systemic sclerosis is a serious, life-threatening autoimmune disease that is characterised by chronic activation of the immune system, damage to blood vessels, and fibrosis (scarring) of the skin, lungs, and other internal organs. Systemic sclerosis affects predominately women in mid-life and is associated with significant morbidity and mortality. There are currently no FDA-approved drug therapies for systemic sclerosis.
Resunab is a novel synthetic oral endocannabinoid-mimic drug that preferentially binds to a receptor called CB2 on immune cells and fibroblasts. Numerous pre-clinical and ex-vivo models have demonstrated that the binding of Resunab to CB2 triggers the production of specialized pro-resolving lipid mediators (SPMs) that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis. This resolution cascade restores chronically activated immune systems back to homeostasis and halts fibrosis, without causing immunosuppression.
"We are very pleased to have achieved another significant regulatory milestone for Resunab for the treatment of systemic sclerosis, following the recently granted FDA Orphan Drug designation in this indication," said Yuval Cohen,CEO of Corbus.
"With Fast Track status, we expect to have the opportunity to accelerate Resunab's clinical development timeline to more expediently bring this potentially impactful drug therapy to individuals with systemic sclerosis."
A Fast Track designation enables more frequent interactions with the US FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.
Corbus is scheduled to begin enrollment and dosing in its phase 2 study of Resunab for the treatment of systemic sclerosis this quarter.
Corbus Pharmaceuticals Holdings, Inc. is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic and serious inflammatory and fibrotic diseases.